NCT01529567

Brief Summary

Patients with a diagnosis of irritable bowel syndrome (IBS) are recruited by self-referral. They are randomized to two 10 weeks of internet-delivered cognitive behavioral programs. Both programs include mindfulness training, education about how excessive avoidant and control behaviors maintain IBS symptoms, and changing of these behaviors to live a richer life. One of the programs also includes instructions on how to perform systematic exposure. The hypothesis of the study is while both groups will show improvement in terms of IBS symptom severity and quality of life, the addition of systematic exposure will lead to more improvement in symptoms.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
311

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 9, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

1.1 years

First QC Date

February 6, 2012

Last Update Submit

February 14, 2013

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (3)

  • Gastrointestinal symptom rating scale

    1 week before randomization

  • Gastrointestinal symptom rating scale

    10 weeks after randomization (i.e. after conclusion of treatment)

  • Gastrointestinal symptom rating scale

    36 weeks after randomization (i.e. 6 months after conclusion of treatment)

Secondary Outcomes (6)

  • Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)

    1 week before randomization

  • Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)

    10 weeks after randomization (i.e. after conclusion of treatment)

  • Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL)

    36 weeks after randomization (i.e. 6 months after conclusion of treatment)

  • Visceral Sensitivity Index (VSI)

    1 week before randomization

  • Visceral Sensitivity Index (VSI)

    10 weeks after randomization (i.e. after conclusion of treatment)

  • +1 more secondary outcomes

Study Arms (2)

CBT without exposure

ACTIVE COMPARATOR
Behavioral: Cognitive Behavioral Therapy without exposure

CBT with exposure

EXPERIMENTAL
Behavioral: Cognitive Behavioral Therapy with exposure

Interventions

Cognitive Behavioral Therapy without exposureBEHAVIORAL

10 week internet-delivered cognitive behavioral therapy, including mindfulness training, education about the negative effects of excessive avoidance and control behaviors on IBS symptoms and quality of life, and guided behavioral change aiming to increase quality of life and flexibility.

CBT without exposure
Cognitive Behavioral Therapy with exposureBEHAVIORAL

10 week internet-delivered cognitive behavioral therapy, including mindfulness training, education about the negative effects of excessive avoidance and control behaviors on IBS symptoms and quality of life, guided behavioral change aiming to increase quality of life and flexibility, and systematic exposure to IBS symptoms and aversive situations.

CBT with exposure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fluency in Swedish
  • IBS-diagnosis established by physician
  • Fulfillment of Rome III criteria for IBS

You may not qualify if:

  • Diarrhea predominance with no colonoscopy performed
  • Blood in stool without benign medical explanation
  • Rapid weight loss without benign medical explanation
  • Ongoing alcohol or drug abuse
  • Suicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wallen H, Lindfors P, Andersson E, Hedman-Lagerlof E, Hesser H, Lindefors N, Svanborg C, Ljotsson B. Return on investment of internet delivered exposure therapy for irritable bowel syndrome: a randomized controlled trial. BMC Gastroenterol. 2021 Jul 13;21(1):289. doi: 10.1186/s12876-021-01867-6.

    PMID: 34256715DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Brjánn Ljótsson, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 6, 2012

First Posted

February 9, 2012

Study Start

November 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 15, 2013

Record last verified: 2013-02